FDA.reportPublic FDA data

Application 071443

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINETABLET;ORAL50MG;4MGNoYes
002PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINETABLET;ORAL10MG;2MGNoNo
003PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINETABLET;ORAL10MG;4MGNoNo
004PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINETABLET;ORAL25MG;2MGNoYes
005PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINETABLET;ORAL25MG;4MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0042Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0042Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0042Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0042Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0073Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0073Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0073Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0073Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0330Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0330Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0330Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0330Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0442Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0442Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0442Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0442Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0574Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0574Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0574Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0574Perphenazine and Amitriptyline Hydrochlorideperphenazine and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18347SUPPL2014-09-05